Food and Drug Regulations

C.02.002 In this Division,

drug

drug[Repealed, SOR/97-12, s. 6]

importer

importer[Repealed, SOR/97-12, s. 6]

medical gas

medical gas means any gas or mixture of gases manufactured, sold or represented for use as a drug; (gaz médical)

packaging material

packaging material includes a label; (matériel d’emballage)

produce

produce[Repealed, SOR/97-12, s. 6]

quality control department

quality control department means a quality control department referred to in section C.02.013; (service du contrôle de la qualité)

specifications

specifications means a detailed description of a drug, the raw material used in a drug or the packaging material for a drug and includes

• (a) a statement of all properties and qualities of the drug, raw material or packaging material that are relevant to the manufacture, packaging and use of the drug, including the identity, potency and purity of the drug, raw material or packaging material,

• (b) a detailed description of the methods used for testing and examining the drug, raw material or packaging material, and

• (c) a statement of tolerances for the properties and qualities of the drug, raw material or packaging material. (spécifications)